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Clinical trial for safety and effectiveness of ophthalmic sealing gel in corneal incision sealing after ophthalmology

Clinical trial for safety and effectiveness of ophthalmic sealing gel in corneal incision sealing after ophthalmology

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028724
Enrollment
Unknown
Registered
2020-01-01
Start date
2019-12-30
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The product is suitable for sealing the corneal incision surface produced by patients after ophthalmology, and it has proved that there is obvious leakage at the incision. The product can quickly soli

Interventions

Group 1:Use ophthalmic seal gel
Group 2:Matrix hydration

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged >=18 years; 2. Cataract phacoemulsification and / or intraocular lens implantation through a transparent corneal incision is planned, and leakage of corneal incision is demonstrated during the operation, including voluntary leakage of the incision and passing through an ocular manometer CFG incision leakage of no more than 1 ounce of force (approximately 28.35 grams); 3. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclude all intraocular infectious inflammations existing before surgery, including bacterial, fungal and viral infections caused by various endogenous or exogenous factors; 2. Exclude sterile intraocular inflammation during the active phase before surgery, including: post uveitis, iridocyclitis, scleritis, retinal arteriovenous obstruction, and diabetic retinopathy; 3. Exclude other fundus diseases that significantly affect postoperative visual quality, including: retinitis pigmentosa, age-related macular degeneration, and macular cystoid edema; 4. Eliminate ocular surface diseases that have a potential risk of infection and affect patients' postoperative comfort, including: chronic lacrimal sac and lacrimal gland inflammation, dry eye and sjogren's syndrome, and blepharitis; 5. Exclude congenital or acquired acquired corneal abnormalities, including: various types of corneal malnutrition, pterygium (smaller pterygium, diameter not exceeding 2mm, distance from incisions, without affecting the degree of corneal regularity, and not blocking the visual axis Can be included in this study), low corneal endothelium count or decompensated corneal endothelium count (corneal endothelium count <1200 / mm2), ICE syndrome, trauma, acid-base chemical burns, and various corneal incisions caused by corneal incision surgery And scars; exclude all types of primary and secondary open-angle and closed-angle glaucoma; 6. Exclude all types of systemic or non-infectious diseases, including: systemic lupus erythematosus, rheumatoid disease, hematological diseases, various types of hepatitis (HBV, C), sexually transmitted diseases (syphilis, etc.), AIDS; 7. Exclude all types of benign and malignant tumors of the eye or system that are suspected or have been diagnosed, and patients who are undergoing radiotherapy and chemotherapy; 8. exclude pregnant, pregnant and lactating women; 9. Exclude patients who participated in other clinical trials within 1 month before enrollment. Patient exclusion criteria during surgery: (1) Those who stumbled during the operation and found no exclusion criteria before the operation; (2) Patients who underwent surgical procedures not planned by the institute during the operation, including: those who underwent slack corneal incisions during surgery, and those who underwent corneal resection with femtosecond laser assistance during the operation; (3) due to the subject's iris relaxation or sudden repulsive suprachoroidal hemorrhage during the operation, which caused the prolapse of the eye tissue through the incision, which could not be accepted or repeatedly prolapsed after being accepted; (4) Corneal incision burns, excessive dilatation, and corneal incision tears caused by surgical instruments and operations during the operation, and the investigator will decide whether to include in the study according to the corneal incision of the subject.

Design outcomes

Primary

MeasureTime frame
Effective corneal incision closure 7 days after surgery;

Secondary

MeasureTime frame
Evaluation of corneal incision closure during and 1 day after operation;;The degree of corneal astigmatism, visual acuity, and the patient's eye comfort index at day 1, 7 and 28 after surgery;;IOP at 1 day, 3 days, 7 days, and 28 days after surgery;;Postoperative wound healing on days 3, 7, and 28;

Countries

China

Contacts

Public ContactZhu Siquan

Beijing Anzhen Hospital

fanfen@nkdpharm.com+86 18501982754

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026